真实世界临床研究伦理问题及策略探讨

Discussion on Solutions to Ethical Issues of Clinical Researches in a Real World

真实世界研究范式已经成为近年国内外临床研究特别是中医药临床研究关注的前沿,本文从伦理的角度,对真实世界研究范式下的临床研究可能存在的伦理问题进行了审视和分析;结合近年来的实践探索,提出了一些在真实世界研究过程中保护受试者、进行伦理审查以及提高科学性和伦理性的初步策略。

The paradigm of a real world study has become the frontiers of clinical researches, especially in the field of Chinese medicine, all over the world in recent years. In this paper, ethical issues which probably exist in real-world studies are raised and reviewed. Moreover, some preliminary solutions to these issues such as protecting subjects during the process of real-world studies and performing ethical review are raised based on recent years′ practices to enhance the scientificity and ethical level of real-world studies.